Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
10 C.F.R. § 35.100
in effectEffective: 2024-07-01Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is—
(a) Obtained from:
(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or
(b) Excluding production of PET radionuclides, prepared by:
(1) An authorized nuclear pharmacist;
(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or
(3) An individual under the supervision, as specified in § 35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section; or
(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-10.xmlFetched: 7/26/2026